Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

Phase 1

Recruiting

• Conditions: PCOS; Polycystic Ovary Syndrome (PCOS); Polycystic Ovary Syndrome
• Interventions: Biological: AlloRx

• Registration Number: NCT06143527
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Detailed Description

Stem cell treatment has shown efficacy for PCOS in both human and animal studies. Complete resolution was seen of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (UCDSC). It is hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Study Timeline

• Study Start: 2023-11-16
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2027-11-16
• Study Completion: 2027-11-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Ultrasound documented poly cystic ovary syndrome

Exclusion Criteria

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety
• Continued drug abuse
• Previous organ transplant
• Hypersensitivity to sulfur
• Inability to supply proper informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group (AlloRx)	AlloRx	Intravenous infusion

Primary Outcome Measures

Name	Time	Method
Safety: Adverse Events	Four year follow-up	Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

Name	Time	Method
Efficacy: Global Improvement Score (GI)	Four year follow-up	Ranging from 0 to 100%

Trial Locations

Locations (2)

Medical Surgical Associates Center; 🇦🇬 St. John's, Antigua and Barbuda

Athens Beverly Hills Medical Group; 🇬🇷 Glyfáda, Greece